RX - TO - OTC. Learning Objectives. Interactive workshop on guiding your organization through and Rx-to-OTC Switch. 4th FEATURED SPEAKERS

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1 4th RX - TO - OTC SWITCH SUMMIT Navigate safety tests, trials, and regulatory compliance while developing complicated business and marketing strategies to ensure a successful switch December 6-7, 2017 Sonesta Philadelphia Rittenhouse Square Philadelphia, PA FEATURED SPEAKERS Sean Griffin, Senior Director of Regulatory Affairs, GALDERMA Erin E. Haas, MPH Prevention Policy Manager, MARYLAND DEPARTMENT OF HEALTH Philip Kantor, former Global Marketing Director, GLAXOSMITHKLINE Juby Jacob-Nara, former CMO and Vice President, Global Clinical Development and Global Medical Affairs, PFIZER James Kenney, Global Brand Marketing Director, GALDERMA Susan Lavine Coleman, President, NCI CONSULTING Learning Objectives Dive into the most recent case studies of successful and failed switches and identify the best practices for ensuring profitability following an Rx-to-OTC switch Interactive workshop on guiding your organization through and Rx-to-OTC Switch Investigate present-day trends and discover how to successfully lead your Rx drug through the OTC switch Explore the role of technology in improving the safety environment for a switch Learn top-notch marketing and branding strategies to commercialize your brand while complying with regulations Susan B. Levy, Founder and Principal, SUSAN B. LEVY CONSULTING The Basic Rx to OTC Switch Process Exchange best practices with those working in regulatory, development, and brand marketing for OTC drugs Key Switch Success Factors Evaluating Switch Opportunities

2 RX -TO- OTC SWITCH SUMMIT WHO SHOULD ATTEND? This conference is designed for professionals from pharmaceutical companies with responsibilities in the following areas: Rx-to-OTC Switches Regulatory Affairs/Regulatory Processes Brand Management/Product Management Brand Marketing Legal Affairs/Counsel/Regulatory Counsel Medical/Scientific Affairs Consumer Healthcare Products Clinical Development Clinical Trials Research and Development Business Strategy Labeling/Packaging Drug Delivery Technology Product Development Corporate Development Portfolio Strategy This conference is also of interest to: Strategy and Marketing Consultants Clinical Research Labs CROs/CMOs Drug After-Market Manufacturers/Suppliers Legal/Regulatory Advisors Statistical Service Providers Marketing/Media Organizations Law Firms SPONSORSHIP AND EXHIBITION OPPORTUNITIES Do you want to spread the word about your organization s solutions and services to potential clients attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs. Dear Colleague, The FDA focuses much of their attention evaluating switch candidates on the safety aspects of a product. In today s switch environment this is creating a unique challenge sponsors. Countless products identified as potential switch candidates 10 years ago are facing generic competition; meaning the original safety and efficacy studies were conducted 15 years ago when measuring and assessing safety methods were underdeveloped. This is causing many companies to reconsider their switch portfolio and face challenges they ve never seen before. For its fourth consecutive year, the Rx-to-OTC Switch Summit brings industry leaders together to provide an advanced understanding of the changing Rx-to-OTC switch landscape and address new challenges head-on. The 4th RX-to-OTC Summit is the most advanced thought leadership event of its kind. Delegates discuss all aspects of a switch from new drug application processes to a final over-the-counter product, including: Basics of the switching process Prelaunch and post-launch factors Case studies and success stories Innovative OTC packaging and adequate label writing Latest regulatory challenges and initiatives Consumer studies Marketing and branding strategies Be sure to attend our pre-conference workshop, How to Guide Your Organization Through an OTC Switch. This workshop focuses on switching a drug from prescription to OTC status in an NDAdriven process. Whether you are new to switch or a veteran in need of a refresher course, Susan Levy, Founder and Principal at Susan B. Levy Consulting, will be able help you modernize your approach for building an Rx-to-OTC switch program. I look forward to welcoming you to Philadelphia this December! Megan Heburn Megan Heburn Conference Production Director ExL Events VENUE SONESTA PHILADELPHIA RITTENHOUSE SQUARE 1800 Market Street, Philadelphia, PA To make reservations, please call SONESTA ( ) and request the negotiated rate for ExL s 4th RX, 6th Content and 2nd Digital Boot Camp. You may make reservations online using the following weblink: The group rate is available until November 14, Please book your room early, as rooms available at this rate are limited. *ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL s reserved guest room block using the details provided.

3 Wednesday, December 6, 2017 Day One 8:00 REGISTRATION AND CONTINENTAL BREAKFAST 9:00 WELCOME AND OPENING REMARKS 9:15 CONFERENCE WORKSHOP HOW TO GUIDE YOUR ORGANIZATION THROUGH AN RX-TO-OTC SWITCH Switching a drug from prescription to OTC status is an expensive, time-consuming NDA-driven process. With rarely more than one switch approved each year in the United States, each switch program is unique, and not all are successful. Nonetheless, Rx-to- OTC switch remains a very effective mechanism for launching new and differentiated consumer brands. This workshop is designed to provide an overview of the switch process to optimize the required clinical, regulatory and marketing investment. Firm up the basics of the switch process Update best practices for building a successful Rx-to-OTC switch program Select the ideal Rx-to-OTC switch candidates Susan B. Levy, Founder and Principal, SUSAN B. LEVY CONSULTING There will be a half-hour networking break at 10:30. 12:15 LUCHEON 1:15 ACCESS AND EMPLOYER/CONSUMER TRENDS THAT IMPACT RX-TO-OTC PRODUCTS Learn Access Trends Related to ACA And ERISA That Impact Rx-To-Otc Future Products Translate What the Trump Administration Wants to Do (FDA, insurance, benefits, reporting, etc.) Pinpoint Middlemen Market Change and Role of Supply Chain Stakeholders in U.S. Discuss Employers As Purchasers And Review Consumers As Payers Regarding Trends That Impact Future Use Of Products Explore strategies to transform threats into product opportunities F. Randy Vogenberg, Ph.D., RPh, Principal, Institute for Integrated Healthcare, Fellow, Foundation of HealthSmart Consumers, Lead Collaborator, NATIONAL INSTITUTE OF COLLABORATIVE HEALTHCARE 2:00 MOVING ORAL CONTRACEPTIVES OTC IN THE US Partnering with advocates and experts to start the process of bringing an over-the-counter oral contraceptive to the US market Discuss the process of working with healthcare providers, advocates and researchers to build evidence and make the case for the benefits of moving a birth control pill OTC Hear how creating a safe and effective OC would help people in the US overcome barriers to accessing the birth control 2:45 NETWORKING BREAK 3:15 SUCCESSFUL SWITCHED CASE STUDY: BEST PRACTICES AND INSIGHT FROM GALDERMA ON SUCCESSFUL RX TO OTC SWITCHES Review the marketing approach used to bring Rx medications to the OTC market Recognize the effect of successful switches on future OTC switches Pinpoint branding techniques to ensure success James Kenney, Global Brand Marketing Director, GALDERMA Sean Griffin, Senior Director of Regulatory Affairs GALDERMA 4:00 NOVEL STRATEGIES TO MAXIMIZE SWITCH COMMERCIAL SUCCESS Explore current and emerging threats to switch brands Discuss strategies to transform threats into brand growth opportunities Review illustrative case examples of brands embracing the future How to guide for identifying and assessing novel strategies Susan Lavine Coleman, President, NCI CONSULTING 4:45 DAY ONE CONCLUDES This event covered all areas of the switch process. Associate Director, Clinical Operations, NOVEN PHARMACEUTICALS Very interactive! Associate Director, CHC, SANOFI

4 Thursday, December 7, 2017 Day Two 8:15 CONTINENTAL BREAKFAST 9:00 CHAIRPERSON S RECAP OF DAY ONE 9:15 PANEL: MEDICAL COMMERCIAL PARTNERSHIP: A KEY TO SUCCESSFUL SWITCH Formulate an integrated and transparent switch plan Communicate and cooperate through every step of the process from identification/evaluation through commercialization and launch Leverage the combined expertise to enhance likelihood of regulatory and commercial success Uncover issues in a timely fashion to optimize mutually acceptable responses Work for competitive advantages to position for success Guide the broader team for maximum efficiency Philip Kantor, former Global Marketing Director, Allergy, GLAXOSMITHKLINE Juby Jacob-Nara, former CMO and Vice President, Global Clinical Development and Global Medical Affairs, PFIZER 10:15 PANEL: DRIVE INNOVATIVE MEDICAL AND REGULATORY STRATEGIES AND INTERACT EFFECTIVELY WITH THE FDA Establish dos and don ts for FDA advisory meeting preparation Assess the regulatory switch landscape from a medical and regulatory point of view Outline ongoing regulatory work Discuss the lessons learned from recent applications Sean Griffin, Senior Director of Regulatory Affairs, GALDERMA 11:00 NETWORKING BREAK 11:30 POTENTIAL FUTURE OTC SWITCHES FROM A PHARMACIST S PERSPECTIVE Discuss current Rx medications that could become OTC switch candidates Identify opportunities to maximize exposure and profitability/savings by making the switch Learn the value of self-care and the importance of access Explore potential federal and state actions that may impact consumer healthcare and OTCs Randall Thornton, Clinical Pharmacist, EMORY HEALTHCARE 12:15 LUNCHEON 1:15 EXPLORE POLICY AND PROGRAM IMPLICATIONS OF A NALOXONE RX-OTC SWITCH Define naloxone, its significance as opioid user self-care, and its role in community-based opioid overdose response Explain the current naloxone distribution policy and program landscape Identify pros and cons of a naloxone Rx-OTC switch Corey Davis, Deputy Director and Staff Attorney, NETWORK FOR PUBLIC HEALTH LAW Erin E. Haas, MPH, Prevention Policy Manager, MARYLAND DEPARTMENT OF HEALTH BEHAVIORAL HEALTH ADMINISTRATION 2:00 UNDERSTAND KEY ELEMENTS OF CONSUMER BEHAVIOR STUDIES IN A COMPLEX RX-TO-OTC SWITCH Determining key communication objectives for your drug facts language in label comprehension studies Testing how consumers actually apply your well-understood label to themselves through self-selection and actual use studies Learn how a full spectrum of consumer behavior studieswas conducted in a successful first-in-class switch Edwin Hemwall, Ph.D., Principal, EDWIN HEMWALL LLC REGULATORY AND SCIENTIFIC CONSULTING SERVICE 2:45 CONFERENCE CONCLUDES Excellent insight! Director, R&D, BAYER CONSUMER CARE A great presentation looking at the hurdles that exist for OTC switches. Regulatory Associate, TEVA Brought up some new points that I did not think of previously. Senior Director of Regulatory Affairs, PERRIGO

5 REGISTRATION INFORMATION MEDIA PARTNERS Standard Pricing Register After Friday, October 20, 2017 Conference $2,095 Onsite Pricing Conference $2,295 Includes Sales Tax and Service Fees GROUP DISCOUNT PROGRAM Offers may not be combined. Early Bird rates do not apply. To find out more on how you can take advantage of these group discounts, please call SAVE 25% PER PERSON WHEN REGISTERING FOUR For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time). This is a savings of 25% per person. SAVE 15% PER PERSON WHEN REGISTERING THREE Can only send three? You can still save 15% off of every registration. TERMS AND CONDITIONS: By registering for an ExL Events ( ExL ) event, you agree to the following set of terms and conditions listed below: REGISTRATION FEE: The fee includes the conference all program materials and designated continental breakfasts lunches and refreshments. PAYMENT: Make checks payable to ExL Events and write C914 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. **Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.** CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event: Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date. Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date. Five days or less: A voucher (minus a $395 processing and documentation fee) to another ExL event valid for 12 months from the voucher issue date. CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees behalf, the credit voucher will no longer be valid. ExL Events does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event. SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference. ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare hotel or any other expenses incurred by registrants. ExL Events liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date content speakers and/or venue. *The opinions of ExL s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events. Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

6 WAYS TO REGISTER Method of Payment: Check Credit Card Make checks payable to ExL Events. Card Type: MasterCard Visa Discover AMEX Card Number: Name on Card: Exp. Date: CVV: Signature: Conference Code: C914 Yes! Register me for the conference and workshop! Yes! Register me for the conference! Please contact me: I'm interested in marketing opportunities at this event. I wish to receive updates on ExL Events upcoming events. Name: Title: Company: Dept.: Address: City: State: Zip: Phone: Fax: 4th RX - TO - OTC SWITCH SUMMIT Navigate safety tests, trials, and regulatory compliance while developing complicated business and marketing strategies to implementing superior branding, labeling, and packaging practices while ensuring a successful switch December 6-7, 2017 Sonesta Philadelphia Rittenhouse Square Philadelphia, PA FEATURED SPEAKERS Sean Griffin, Senior Director of Regulatory Affairs, GALDERMA Erin E. Haas, MPH Prevention Policy Manager, MARYLAND DEPARTMENT OF HEALTH Philip Kantor, former Global Marketing Director, GLAXOSMITHKLINE Juby Jacob-Nara, former CMO and Vice President, Global Clinical Development and Global Medical Affairs, PFIZER James Kenney, Global Brand Marketing Director, GALDERMA Susan Lavine Coleman, President, NCI CONSULTING